Valsartan and Amlodipine Compared to Losartan and Amlodipine in Hypertensive Patients
Primary Purpose
Essential Hypertension
Status
Unknown status
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
valsartan/amlodpine
losartan/amlodpine
Sponsored by
About this trial
This is an interventional treatment trial for Essential Hypertension
Eligibility Criteria
Inclusion Criteria:
- diastolic blood pressure in sitting position 100 to 109 mmHg and systolic blood pressure > 140 mmHg at the end of the selection period
Exclusion Criteria:
- type 2 diabetes mellitus
- heart failure
- AMI in the previous 6 months
- angina pectoris
- secondary hypertension
- malignant hypertension
- women child-bearing potential
- women who are pregnant and lactating
- suspected history of allergy to the sartans or calcium channels blockers
Sites / Locations
- Giuseppe DerosaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
valsartan/amlodipine
losartan/amlodpine
Outcomes
Primary Outcome Measures
24 hours mean, determinated through ABPM; diastolic mean after 4 weeks of losartan 100mg/amlodipine 5mg and valsartan 160mg/amlodipine 5mg treatment
Secondary Outcome Measures
24 hours systolic mean, determinated through ABPM; day systolic and diastolic mean determinated through ABPM; night systolic and diastolic mean determinated through ABPM
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00716950
Brief Title
Valsartan and Amlodipine Compared to Losartan and Amlodipine in Hypertensive Patients
Official Title
Evaluation of Antihypertensive Activity of Valsartan and Amlodipine Compared to Losartan and Amlodipine Through Ambulatory Blood Pressure Monitoring in Moderate Hypertensive Patients in a Randomized, Controlled, Double-Blind Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2008
Overall Recruitment Status
Unknown status
Study Start Date
July 2008 (undefined)
Primary Completion Date
February 2009 (Anticipated)
Study Completion Date
February 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University of Pavia
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Hypertensive patients with moderate hypertension have a risk to develop cardiovascular events of 15-20% over a period of 10 years. It is important to reach quickly the advised target, but often this result can be obtained with a combination therapy. Some evidences demonstrate sartans and calcium channels blockers can be very useful and safe, but it is also important to verify which association can give side effects or give some pharmacokinetic interactions that can negatively influence the clinical combination efficacy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
187 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
valsartan/amlodipine
Arm Title
2
Arm Type
Active Comparator
Arm Description
losartan/amlodpine
Intervention Type
Drug
Intervention Name(s)
valsartan/amlodpine
Intervention Description
tablets; 160mg/5mg; od; 4 weeks
Intervention Type
Drug
Intervention Name(s)
losartan/amlodpine
Intervention Description
tablets; 100mg/5mg; od; 4 weeks
Primary Outcome Measure Information:
Title
24 hours mean, determinated through ABPM; diastolic mean after 4 weeks of losartan 100mg/amlodipine 5mg and valsartan 160mg/amlodipine 5mg treatment
Time Frame
after 4 weeks
Secondary Outcome Measure Information:
Title
24 hours systolic mean, determinated through ABPM; day systolic and diastolic mean determinated through ABPM; night systolic and diastolic mean determinated through ABPM
Time Frame
after 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
diastolic blood pressure in sitting position 100 to 109 mmHg and systolic blood pressure > 140 mmHg at the end of the selection period
Exclusion Criteria:
type 2 diabetes mellitus
heart failure
AMI in the previous 6 months
angina pectoris
secondary hypertension
malignant hypertension
women child-bearing potential
women who are pregnant and lactating
suspected history of allergy to the sartans or calcium channels blockers
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roberto Fogari, MD
Phone
+39 0382 526217
Email
r.fogari@unipv.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberto Fogari, MD
Organizational Affiliation
University of Pavia
Official's Role
Study Chair
Facility Information:
Facility Name
Giuseppe Derosa
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giuseppe Derosa, MD
Phone
+39 0382 502614
Email
giuseppe.derosa@unipv.it
First Name & Middle Initial & Last Name & Degree
Giuseppe Derosa, MD, PhD
12. IPD Sharing Statement
Learn more about this trial
Valsartan and Amlodipine Compared to Losartan and Amlodipine in Hypertensive Patients
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